Phase III trial of Epidiolex (cannabidiol) meets primary endpoint in Lennox-Gastaut syndrome- GW Pharmaceuticals

GW Pharmaceuticals has announced positive results of the first randomized, double-blind, placebo-controlled Phase III clinical trial of Epidiolex (cannabidiol or CBD) for the treatment of Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In this trial, Epidiolex, when added as an adjunct to the patient�s current treatment, achieved the primary endpoint of a significant reduction in the monthly frequency of drop seizures assessed over the entire 14-week treatment period compared with placebo.

During the treatment period, patients taking Epidiolex achieved a median reduction in monthly drop seizures of 44 percent compared with a reduction of 22 percent in patients receiving placebo, and the difference between treatments was statistically significant. This trial follows the announcement in March 2016 of positive results in a pivotal Phase III trial of Epidiolex for the treatment of Dravet syndrome. Epidiolex has Orphan Drug Designation from the FDA for the treatment of LGS and Dravet syndrome.

Epidiolex was generally well tolerated in this trial. Overall, 86 percent of all Epidiolex patients experienced an adverse event compared with 69 percent of patients on placebo. The most common adverse events (occurring in greater than 10 percent of Epidiolex-treated patients) were: diarrhea, somnolence, decreased appetite, pyrexia, and vomiting. Further data will be presented in future publications and medical meetings.